A multicenter, multinational, randomized, parallel group, placebo-controlled, double-blind study to evaluate efficacy and safety of a food supplement containing 80 mg soy isoflavones ZAVITAL in the control of climacteric syndrome in postmenopausal women - ND
- Conditions
- Menopausal syndromeMedDRA version: 8.1Level: LLTClassification code 10058825Term: Menopausal disorder
- Registration Number
- EUCTR2006-000191-32-IT
- Lead Sponsor
- ZAMBON GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 360
61485;Post menopausal women aged between 40-65, with at least 6 months since the last menstrual period or 6 weeks from bilateral oophorectomy, and the serum levels of FSH 8805; 30 IU/L and estradiol 8804; 40 pg/ml at baseline. 61485;Patients with a minimum average of 5 moderate to severe hot flushes including night sweats in 24h during the last 7 days on patient s diary before randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
61485;Concomitant therapies such as Hormone Replacement Therapy HRT and any other hormone therapies estrogens, progesterone, androgens in the last 3 months before the inclusion into the study; other agents for the treatment of hot flushes such as megestrol acetate, clonidine, vitamin E, phenobarbital, ergotamine tartrate, antidepressant agents and patients habitually taking 4 days a week products containing isoflavones in the last month before screening visit. 61485;Patients with severe hepatic failure AST and ALT twice the upper limit , renal failure creatinine 1.5 mg/dl , diabetes mellitus type I or uncontrolled type II , uncontrolled dysthyroidism, manifest heart failure condition NYHA II-IV , severe neurologic diseases, as well as patients with hypersensitivity to soy products. 61485;Patients with previous breast cancer in the last 5 years or suspected breast nodules at physical examination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show superiority of a 12 week treatment with Zavital over placebo in reduction of frequency of hot flushes in post-menopausal women;Secondary Objective: 61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of intensity of vasomotor symptoms 61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of all climacteric symptoms Greene Climacteric Scale 61485;To evaluate the safety of a 12-week treatment with Zavital in terms of incidence of adverse events, vital signs and laboratory evaluations. 61485;To evaluate the global efficacy and tolerability of a 12-week treatment with Zavital ;Primary end point(s): The primary efficacy variable is the change from baseline in the mean daily frequency of moderate and severe hot flushes during the last 7 days on patient s diary prior to visit of mid-treatment 6th week , first of all, and secondly at the end-of treatment 12th week
- Secondary Outcome Measures
Name Time Method